Surgical implants including sensing fibers

ABSTRACT

A monitoring system includes a surgical implant configured for implantation in vivo and having at least one sensing fiber configured to measure a preselected physiological parameter, and a receiving unit in wireless communication with the at least one sensing fiber and configured to receive measurements of the preselected physiological parameter. A surgical system includes an end effector having a plurality of fasteners, and a surgical implant securable to tissue via the plurality of fasteners. The surgical implant includes at least one sensing fiber configured to measure a preselected physiological parameter.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/892,551, filed on Feb. 9, 2018 (now U.S. Pat. No. 11,096,610), whichclaims the benefit of, and priority to, U.S. Provisional PatentApplication Ser. No. 62/599,232, filed on Dec. 15, 2017 and U.S.Provisional Patent Application Ser. No. 62/477,458, filed on Mar. 28,2017, the entire content of each of which is hereby incorporated byreference herein.

BACKGROUND Technical Field

The present disclosure relates to surgical implants including sensingfibers for post-operative monitoring. Embodiments of the presentdisclosure relate to surgical buttresses that are releasably attached toa surgical stapling apparatus, and in particular, to a surgical buttressincluding sensing fibers for detecting tissue conditions along a stapleline and transmitting the tissue conditions to a remote device.Embodiments of the present disclosure relate to a surgical meshincluding sensing fibers for detecting tissue conditions at a softtissue repair site and transmitting the tissue conditions to a remotedevice.

Background of Related Art

Surgical stapling apparatus are employed by surgeons to sequentially orsimultaneously apply one or more rows of fasteners, e.g., staples ortwo-part fasteners, to body tissue for the purpose of joining segmentsof body tissue together and/or attaching a surgical implant to bodytissue. Such apparatus generally include a pair of jaws or finger-likestructures between which the body tissue to be joined is placed. Whenthe stapling apparatus is actuated, or “fired”, longitudinally movingfiring bars contact staple drive members in one of the jaws. The stapledrive members push the surgical staples through the body tissue and intoan anvil in the opposite jaw which forms the staples. If tissue is to beremoved or separated, a knife blade can be provided in the jaws of theapparatus to cut the tissue between the lines of staples.

Surgical supports, e.g., meshes or buttress materials, may be used incombination with surgical stapling apparatus to bridge, repair and/orreinforce tissue defects within a patient such as those occurring, forexample, in the abdominal wall, chest wall, diaphragm, ormusculo-aponeurotic areas of the body. A buttress material may reinforcea staple or suture line as well as cover the juncture of tissues toreduce leakage prior to healing. A mesh or patch may reinforce, replace,and/or augment soft tissue such as, the abdominal wall in the case ofhernia repair.

For example, following surgery on the gastrointestinal system in whichthe bowel undergoes anastomosis, a possibility exists that an incidencemay arise/develop of subsequent leakage from the bowel into theperitoneal cavity. The result of this development (e.g., impacts onmorbidity and mortality) dramatically affects the patient's prognosisand largely impacts the cost of treatment. Leak detection is generallyaccomplished by monitoring clinical signs of infection, including whiteblood cell count, fever, malaise, heart rate, etc. A factor of usingclinical signs is that there is a lag between the time the leak occursand the onset of signs or symptoms. This may result in an escalation ofthe condition prior to its detection and the appropriate treatment beinginstituted.

Imaging modalities, such as fluoroscopy, may be utilized to monitor forleak detection after administering radiopaque dye orally or rectally.Imaging modalities, however, have limitations of sensitivity andspecificity, and require significant resources and cost to perform.Additional leak detection attempts of measuring effluent from drainshave demonstrated some success. Limitations of this approach, however,include the inconsistent use of drains due to concomitant effects (e.g.,infection, clogging, migration, etc.) and identification of markers fromdrain fluid may be delayed significantly after the leak occurs.

As another example, post-surgical complications may arise after anabdominal wall hernia repair procedure. The performance of a herniarepair using a mesh fixed to an abdominal wall depends, in part, uponshear forces exerted upon the mesh and/or experienced at fixation pointsof the mesh to tissue due to, for example, changes in intra-abdominalpressure. Tearing, breakage, and/or bulging of the mesh may compromisethe surgical repair of the hernia defect, or lead to mesh failure.

While devices and methods are available in attempts of identifyingpost-surgical complications, such as leaks and/or implant compromise, itwould be advantageous to provide a real time non-invasive monitoringsystem for effective early detection of issues associated with apatient's health. Such a system would provide a clinician with a methodof evaluating critical predictors of morbidity and mortality in patientsin real time following surgery and/or tissue trauma. Acute stagedetection would allow for early intervention resulting in improvedpatient outcomes. Additionally or alternatively, it would beadvantageous to include a real time monitoring system as part of apost-operative regimen for improving patient recovery following surgicaltrauma and/or stress.

SUMMARY

A monitoring system in accordance with aspects of the present disclosureincludes a surgical implant configured for implantation in vivo andhaving at least one sensing fiber configured to measure a preselectedphysiological parameter, and a receiving unit in wireless communicationwith the at least one sensing fiber and configured to receivemeasurements of the preselected physiological parameter.

The surgical implant may include a porous layer, and the at least onesensing fiber may be disposed within the porous layer. The surgicalimplant may be formed from a plurality of fibers, and the at least onesensing fiber may be incorporated into the plurality of fibers. Thesurgical implant may include a non-porous layer, and the at least onesensing fiber may be disposed within the non-porous layer.

In some aspects, the at least one sensing fiber is an optical fiber. Incertain aspects, the preselected physiological parameter measured by theat least one sensing fiber is pH, in some other aspects, the preselectedphysiological parameter measured by the at least one sensing fiber is aquantity of an analyte, and in yet other aspects, the preselectedphysiological parameter measured by the at least one sensing fiber isforce.

The at least one sensing fiber may include a core and a sheath disposedover the core. The core may include a semiconducting element, aconducting element, and an insulating element. In some aspects, the coreincludes a semiconducting element and a plurality of conducting elementsin contact with the semiconducting element. In certain aspects, theplurality of conducting elements is electrically connected in a circuit.

A surgical system in accordance with aspects of the present disclosureincludes an end effector having a plurality of fasteners and a surgicalimplant securable to tissue via the plurality of fasteners. The surgicalimplant includes at least one sensing fiber configured to measure apreselected physiological parameter.

In some aspects, the at least one sensing fiber is an optical sensor.The at least one sensing fiber may include a core and a sheath disposedover the core. The core may include a semiconducting element, aconducting element, and an insulating element. In some aspects, the coreincludes a semiconducting element and a plurality of conducting elementsin contact with the semiconducting element. In certain aspects, theplurality of conducting elements is electrically connected in a circuit.

The surgical implant may be a surgical buttress releasably attached tothe end effector. The surgical implant may be a surgical mesh includinga plurality of fibers.

A surgical stapling apparatus in accordance with aspects of the presentdisclosure includes an end effector having a staple cartridge assemblyand an anvil assembly, and a surgical buttress releasably attached tothe staple cartridge assembly or the anvil assembly. The surgicalbuttress includes at least one sensing fiber configured to measure apreselected physiological parameter.

The surgical buttress may include a porous layer in which the at leastone sensing fiber is disposed and/or a non-porous layer in which the atleast one sensing fiber is disposed. In some aspects, the at least onesensing fiber is an optical sensor. In certain aspects, the preselectedphysiological parameter measured by the at least one sensing fiber ispH.

The at least one sensing fiber of the surgical buttress may include acore and a sheath disposed over the core. The core may include asemiconducting element, a conducting element, and an insulating element.In some aspects, the core includes a semiconducting element and aplurality of conducting elements in contact with the semiconductingelement. In certain aspects, the plurality of conducting elements iselectrically connected in a circuit.

A monitoring system in accordance with aspects of the present disclosureincludes a surgical buttress and a receiving unit. The surgical buttressis configured for implantation in vivo and includes at least one sensingfiber configured to measure a preselected physiological parameter. Thereceiving unit is in wireless communication with the at least onesensing fiber and configured to receive measurements of the preselectedphysiological parameter.

The surgical buttress may include a porous layer in which the at leastone sensing fiber is disposed and/or a non-porous layer in which the atleast one sensing fiber is disposed. In some aspects, the at least onesensing fiber is an optical sensor. In certain aspects, the preselectedphysiological parameter measured by the at least one sensing fiber ispH.

The at least one sensing fiber of the surgical buttress may include acore and a sheath disposed over the core. The core may include asemiconducting element, a conducting element, and an insulating element.In some aspects, the core includes a semiconducting element and aplurality of conducting elements in contact with the semiconductingelement. In certain aspects, the plurality of conducting elements iselectrically connected in a circuit.

A method of in vivo monitoring of an anastomosis in real time includes:securing a surgical buttress to tissue, the surgical buttress includingat least one sensing fiber configured to measure a preselectedphysiological parameter; and monitoring the preselected physiologicalparameter via data wirelessly received by a receiving unit from the atleast one sensing fiber of the surgical buttress. In aspects, the methodfurther includes: positioning a body portion of a surgical staplingdevice including a staple cartridge assembly adjacent a first tissue andpositioning an anvil assembly of the surgical stapling device adjacent asecond tissue, the staple cartridge assembly or the anvil assemblyincluding the surgical buttress releasably retained thereon; and firingthe surgical stapling device to mechanically secure the surgicalbuttress and the first and second tissues with staples from the staplecartridge assembly along a staple line.

Other aspects, features, and advantages will be apparent from thedescription, drawings, and the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the present disclosure are described herein belowwith reference to the drawings, which are incorporated in and constitutea part of this specification, wherein:

FIG. 1 is a top view of a surgical implant in accordance with anembodiment of the present disclosure;

FIG. 2 is a side view of a surgical implant in accordance with anotherembodiment of the present disclosure;

FIG. 3 is a schematic illustration of a monitoring system including asensing fiber of the surgical implant of FIG. 1 or FIG. 2, and areceiving unit in accordance with an embodiment of the presentdisclosure;

FIG. 4 is a perspective view of a surgical stapling apparatus includinga surgical buttress disposed on an anvil assembly of the surgicalstapling apparatus and a surgical buttress disposed on a staplecartridge assembly of the surgical stapling apparatus in accordance withan embodiment of the present disclosure;

FIG. 5 is a perspective view of a distal end of the surgical staplingapparatus of FIG. 4, shown in use and positioned about tissue;

FIG. 6 is a cross-sectional view of the distal end of the surgicalstapling apparatus of FIGS. 4 and 5, taken along line 6-6 of FIG. 5;

FIG. 7 is a perspective view of the stapled and divided tissue of FIG.6;

FIG. 8 is a perspective view of a surgical stapling apparatus inaccordance with another embodiment of the present disclosure;

FIG. 9 is a cross-sectional view of the surgical stapling apparatus ofFIG. 8 including a surgical buttress disposed on an anvil assembly ofthe surgical stapling apparatus and a surgical buttress disposed on astaple cartridge assembly of the surgical stapling apparatus inaccordance with an embodiment of the present disclosure;

FIG. 10 is a top view of one of the surgical buttresses of FIG. 9; and

FIG. 11 is a top view of a surgical mesh in accordance with anembodiment of the present disclosure, shown secured to tissue viasurgical staples.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The present disclosure is directed to surgical implants, systems, andmethods of using the same for measuring physiological parameters in realtime. The physiological parameters may be associated with acute and/orchronic tissue compromise or failure in one or multiple tissue/organsites. The present disclosure describes embodiments of surgical implantsfor real time monitoring of physiological parameters, surgical staplingapparatus supporting and/or securing said surgical implants to tissue,monitoring systems including said surgical implants and a receiving unitfor analysis of the physiological parameters, and exemplarycorresponding methods of use in accordance with principles of thepresent disclosure.

The presently disclosed surgical implants may be any medical device,such as scaffolds, grafts, patches, slings, pledgets, growth matrices,drug delivery devices, wound plugs, and, in general, may be soft tissuerepair devices and/or surgical prostheses. It should be understood thatthe surgical implants may also be utilized as topically applied medicalproducts, such as wound dressings, coverings, and the like, that can beused in medical/surgical procedures. The principles of the presentdisclosure are related to monitoring of surgical and medical treatmentsof disease and body ailments of a patient, such as necrosis, infection,and cancer. For example, devices, systems, and methods of the presentdisclosure may be utilized in the detection of infection, metabolicdisorder, or abnormal or non-ideal conditions of wound healing.

Embodiments of the presently disclosed surgical implants will now bedescribed in detail with reference to the drawing figures wherein likereference numerals identify similar or identical elements. Throughoutthis description, the term “proximal” refers to a portion of astructure, or component thereof, that is closer to a clinician, and theterm “distal” refers to a portion of the structure, or componentthereof, that is farther from the clinician. As used herein, the term“patient” should be understood as referring to a human subject or otheranimal, and the term “clinician” should be understood as referring to adoctor, nurse, or other care provider and may include support personnel.

Referring now to FIG. 1, a surgical implant 10 in accordance with thepresent disclosure is shown. The surgical implant 10 may have any shape,size, and/or dimension suitable for its intended application as shouldbe understood by those skilled in the art. The surgical implant 10 isfabricated from biocompatible materials which are bioabsorbable ornon-absorbable, natural or synthetic materials. It should be understoodthat any combination of natural, synthetic, bioabsorbable, and/ornon-bioabsorbable materials may be used to form the surgical implant 10.

The surgical implant 10 may be porous, non-porous, or combinationsthereof. Suitable porous structures include, for example, fibrousstructures (e.g., knitted structures, woven structures, and non-wovenstructures) and/or foams (e.g., open or closed cell foams). Suitablenon-porous structures include, for example, films. The surgical implant10 described herein may be a single porous or non-porous layer, orinclude a plurality of layers including any combination of porous andnon-porous layers. For example, a surgical implant may include multipleporous and non-porous layers that are stacked in an alternating manner.In another example, a surgical implant may be formed in a“sandwich-like” manner wherein the outer layers of the surgical implantare porous and the inner layer(s) are non-porous.

Porous layer(s) in the surgical implant may enhance the ability of thesurgical implant to absorb fluid, reduce bleeding, and seal the wound.Also, the porous layer(s) may allow for tissue ingrowth to fix thesurgical implant in place. Non-porous layer(s) in the surgical implantmay enhance the ability of the surgical implant to resist tears andperforations during the manufacturing, shipping, handling, and securing(e.g., stapling) processes. Also, non-porous layer(s) may retard orprevent tissue ingrowth from surrounding tissues thereby acting as anadhesion barrier and preventing the formation of unwanted scar tissue.

As shown in FIG. 1, the surgical implant 10 includes a single porouslayer 12 having a fibrous structure. The porous layer 12 is formed froma plurality of interconnected fibers 14. The fibers 14 may bebiocompatible polymeric and/or metallic materials in the form offilaments, threads, and/or yarns that are, for example, knitted or woventogether, or may be staple fibers such as those used for preparingnon-woven materials. Suitable techniques for assembling the fibers 14are within the purview of those skilled in the art. The porous layer 12of the surgical implant 10 further includes one or more sensing fibers20 assembled with the fibers 14, or otherwise incorporated into theporous layer 12 of the surgical buttress 10, in a desired configurationbased on, for example, in vivo sensing needs.

As discussed above, the surgical implant 10 may have otherconfigurations. For example, as shown in FIG. 2, a surgical implant 10 aincludes a porous layer 12 a and a non-porous layer 12 b. Sensingfiber(s) 20 may be disposed in either or both the porous and non-porouslayers 12 a, 12 b. It should be understood that at least one sensingfiber 20 is associated with a surgical implant 10, 10 a and that thesensing fiber(s) may be disposed within a porous layer (e.g., fibrousstructure or foam), a non-porous layer (e.g., a film), or combinationsthereof depending on the configuration of the surgical implant 10, 10 a.

Referring now to FIG. 3, the sensing fiber 20 is a sensor configured tomeasure a preselected physiological parameter of interest and totransmit signals relating to the physiological parameter to a receivingunit 30. The preselected physiological parameter may be a mechanicalcharacteristic (e.g., relaxation, creep, etc.) of the tissue to whichthe surgical implant 10, 10 a (FIGS. 1-2, respectively) is secured, or asubstance (e.g., analytes, biomarkers, etc.) in the tissue and/or thetissue environment indicative of a physiological condition or state suchas, for example, tissue perfusion, tissue ischemia, tissue reperfusion,infection, etc.

The sensing fiber 20 may be: an optical or electrical sensor formeasuring characteristics such as impedance, temperature, pH, thepresence and/or level of analytes, etc.; a mechanical sensor formeasuring, for example, characteristics such as force, stress, strain,etc.; a conductivity or resistivity sensor for measuring, for example,ionic concentration of a compound; among other sensors within thepurview of those skilled in the art for physical or chemical sensing. Itshould be understood that a surgical implant 10, 10 a may includemultiple sensing fibers 20 that measure the same or differentcharacteristics.

With continued reference to FIG. 3, the sensing fiber 20 includes a core22 configured to measure and transmit signals related to the preselectedphysiological parameter to the receiving unit 30, and a sheath 24disposed over the core 22. While the sensing fiber 20 is shown having acircular cross-section, it should be understood that the sensing fiber20 may have other cross-sectional shapes such as, for example,elliptical, triangular, and rectangular, among other regular andirregular shapes. Additionally, it should be understood that the core 22may be off-center with respect to the sheath 24 or a plurality of cores22 may be disposed within the sheath 24 such that the sensing fiber 20exhibits an islands-in-the-sea arrangement where two or more “islands”(e.g., cores) are surrounded by a “sea” (e.g., sheath).

The core 22 includes one or more semiconducting elements 22 a formeasuring the physiological parameter, one or more conducting elements22 b (e.g., electrodes) connected in a circuit, and one or moreinsulating elements 22 c disposed between and/or around thesemiconducting and/or conducting elements 22 a, 22 b. The semiconductingelement(s) 22 a of the core 22 may be formed from a chalcogenide glass,the conducting element(s) 22 b of the core 22 may be formed from a metalor metal alloy, and the insulating element(s) 22 c of the core 22 and/orthe sheath 24 may be formed, for example, from a thermoplastic polymeror copolymer such as polyetherether ketone, polyetherimide, polyethersulfone, polysulfone, polycarbonate, polyethylene, polymethylmethacrylate, or polytetrafluoroethylene.

The semiconducting, conducting, and insulating elements 22 a, 22 b, 22 care configured in a specific geometry (e.g., with selected materialinterfaces) during fabrication of the sensing fiber 20 to enable adesired sensing functionality. Accordingly, it should be understood thatthe core 22 of the sensing fiber 20 may have any of a variety ofconfigurations (e.g., the core 22 can be solid or include spaces orgaps, may be symmetrical or non-symmetrical, etc.).

The sensing fiber 20 is wireless and may be powered externally via,e.g., radiofrequency or magnetic telemetry, to run continuously or beactivated intermittently. The receiving unit 30 is an extracorporealdevice configured to communicate with the sensing fiber 20 via awireless (e.g., radiofrequency, optical, WiFi, Bluetooth®, LTE, etc.)connection to collect the signals from the sensing fiber 20 in real timeand to process the signals into digital data. The receiving unit 30 maybe a portable electronic device which may be worn by a patient (e.g., awristwatch or transcorporeal patch), or otherwise carried by the patient(e.g., a mobile device such as a cell phone, or a unit disposed within acarrying case) to allow for patient mobility during post-surgicalmonitoring.

The signals/data collected by the receiving unit 30 may also be sent toa mobile device of a clinician or be transmitted to a cloud such that aclinician can access the information. The receiving unit 30 may providea sensor alert via an indicator (e.g., a visual, audio, or other sensoryindicator) to the patient and/or a clinician when a predetermined testcriterion is met to allow for appropriate medical response based on theinformation received. The signals produced by the sensing fiber 20contain information about a specific characteristic of the tissue and/ortissue environment which, in turn, imparts information about a conditionor state of the tissue which can be utilized in determining a propercourse of treatment.

With reference now to FIGS. 4-10, various exemplary embodiments of thesurgical implants of the present disclosure are discussed in terms ofsurgical buttresses for use with surgical stapling apparatus. Whilethese embodiments are directed to the detection of leaks ofgastrointestinal content into the abdomen following anastomosis, it isenvisioned that the principles of the present disclosure are equallyapplicable to a range of in vivo diagnostic applications, as discussedabove.

The surgical buttresses may be used in sealing a wound by approximatingthe edges of wound tissue between a staple cartridge assembly and ananvil assembly of a surgical stapling apparatus which includes at leastone surgical buttress having sensing fiber(s). The surgical buttress isreleasably attached to the surgical stapling apparatus such that staplesfired from the surgical stapling apparatus attach the surgical buttressto tissue. The sensing fibers of the surgical buttress measure aphysiological parameter of the tissue and/or tissue environment andtransmit the data to a receiving unit for monitoring by a clinician orthe patient.

It should be understood that a variety of surgical stapling apparatusmay be utilized with a surgical buttress of the present disclosure. Forexample, linear staplers may be utilized, such as, for example thoseincluding Duet TRS™ reloads and staplers with Tri-Staple™ technology,available through Medtronic, formerly Covidien (North Haven, Conn.), aswell as other anastomosis staplers, such as, for example, EEA™, CEEA™,GIA™, EndoGIA™, and TA™, also available through Medtronic. It shouldalso be appreciated that the principles of the present disclosure areequally applicable to surgical staplers having a variety ofconfigurations, such as, for example, end-to-end anastomosis staplershaving a circular cartridge and anvil (see, e.g., commonly owned U.S.Pat. No. 5,915,616, entitled “Surgical Fastener Applying Apparatus,” theentire content of which is incorporated herein by this reference);laparoscopic staplers (see, e.g., commonly owned U.S. Pat. Nos.6,330,965 and 6,241,139, each entitled “Surgical Stapling Apparatus,”the entire contents of each of which being incorporated herein by thisreference); and transverse anastomosis staplers (see, e.g., commonlyowned U.S. Pat. Nos. 5,964,394 and 7,334,717, each entitled “SurgicalFastener Applying Apparatus”, the entire contents of each of which beingincorporated herein by this reference).

It is additionally appreciated that the principles of the presentdisclosure are equally applicable to powered handheld electromechanicalsurgical staplers having a variety of configurations, such as, forexample, those shown and described in U.S. Patent ApplicationPublication No. 2015/0297199, the entire content of which isincorporated herein by this reference.

Referring now to FIG. 4, an exemplary surgical stapling apparatus orsurgical stapler 100 is shown for use in stapling tissue and applying asurgical implant in the form of a buttress material or surgical buttress11 to the tissue. The surgical stapling apparatus 100 generally includesa handle assembly 110, an elongate tubular body portion 120 extendingdistally from the handle assembly 110, and an end effector or jawassembly 130 extending distally from the elongate tubular body portion120. The jaw assembly 130 includes an anvil assembly 140 including astaple clinching anvil jaw member 142 and a staple cartridge assembly150 including a cartridge receiving jaw member 152 housing a staplecartridge 154. The jaw assembly 130 may be permanently affixed to theelongate tubular body portion 120 or may be detachable with respect tothe elongate tubular body portion 120 and thus, replaceable with a newjaw assembly 130. Additionally or alternatively, the staple cartridge154 may be removable and replaceable in the receiving jaw member 152 ofthe staple cartridge assembly 150. The anvil assembly 140 is pivotablewith respect to the elongate tubular body portion 120 and is movablebetween an open position spaced apart from the staple cartridge assembly150 and a closed position substantially adjacent the staple cartridgeassembly 150. It is envisioned that, additionally or alternatively, thestaple cartridge assembly 150 may be pivotable with respect to theelongate tubular body portion 120.

The surgical stapling apparatus 100 further includes a trigger 112movably mounted on the handle assembly 110. Actuation of the trigger 112initially operates to move the anvil assembly 140 from the open positionto the closed position relative to staple cartridge assembly 150 andsubsequently actuates the surgical stapling apparatus 100 to apply linesof staples to tissue captured between the anvil and staple cartridgeassemblies 140, 150. Specifically, a driver 116 is provided to move theanvil jaw member 142 between the open and closed positions relative tothe receiving jaw member 152. The driver 116 moves between alongitudinal slot 141 formed in the anvil jaw member 142, and a knife118 (FIG. 6) associated with the driver 116 cuts tissue captured betweenthe anvil and staple cartridge assemblies 140, 150 as the driver 116passes through the longitudinal slot 141 of the anvil jaw member 142, asdescribed in further detail below.

In order to properly orient the jaw assembly 130 relative to the tissueto be stapled, the surgical stapling apparatus 100 includes a rotationknob 114 mounted on the handle assembly 110. Rotation of the rotationknob 114 relative to the handle assembly 110 rotates the elongatetubular body portion 120 and the jaw assembly 130 relative to the handleassembly 110 so as to properly orient the jaw assembly 130 relative tothe tissue to be stapled.

With continued reference to FIG. 4, respective surgical buttresses 11are releasably attached to tissue facing surfaces (not explicitly shown)of the anvil assembly 140 and the staple cartridge assembly 150. Thesurgical buttress 11 may be releasably attached to the anvil assembly140 and/or the staple cartridge assembly 150 via any suitable attachmentfeature within the purview of those skilled in the art, such as chemicalattachment features (e.g., adhesives) and mechanical attachment features(e.g., mounting structures, such as pins or straps). The surgicalbuttress 11 is provided to reinforce and seal staple lines applied totissue by the surgical stapling apparatus 100 and to measure apreselected physiological parameter of the tissue and/or the tissueenvironment.

It should be understood that while the surgical buttresses 11 are shownand described herein as being associated with both the anvil assembly140 and the staple cartridge assembly 150, the surgical buttresses maybe the same or different, or may only be associated with either theanvil assembly or the staple cartridge assembly, depending on, forexample, the surgical application and/or desired placement andmonitoring as should be understood by a person of ordinary skill in theart.

The surgical buttress 11 may have any shape, size, and/or dimensionsuitable to fit a surgical stapling apparatus. The surgical buttress isfabricated from biocompatible material(s) and may be porous, non-porous,or combinations thereof, as discussed above. The surgical buttress 10 aincludes at least one sensing fiber 20 (FIG. 3). In some embodiments,the surgical buttress 11 is configured the same as, or similar to,surgical implant 10 or 10 a (FIGS. 1-2, respectively).

In embodiments, the sensing fiber 20 of the surgical buttress 11 isconfigured to measure a physiological parameter of interest related tomonitoring for anastomosis leakage about a staple line. In someembodiments, the sensing fiber 20 is an optical pH sensor adapted tomeasure changes in pH in the tissue environment adjacent the stapleline. In some embodiments, the sensing fiber 20 is a chemical sensoradapted to detect the presence of an analyte indicative of anastomoticleakage. The analyte to be detected can be an endogenous material thatwould normally only be present within a patient's body (e.g.,intestines, etc.) such as E. coli or blood, or an exogenous materialintroduced into the patient's body and that remains within the bodyunless leakage occurs.

As shown in FIG. 5, during use of the surgical stapling apparatus 100,the anvil assembly 140 and the staple cartridge assembly 150, which haveeach been loaded with a surgical buttress 11, are positioned on opposedsides of a surgical site where adjacent first and second layers oftissue “T” are to be fastened to one another.

As shown in FIG. 6, the staple cartridge 154 includes surgical staples156 positioned within individual staple pockets 158. The staples 156 areof a conventional type with each including a backspan 156 a and a pairof legs 156 b extending from the backspan 156 a and terminating intissue penetrating tips 156 c. Staple pushers 160 are located within thestaple pockets 158 and are positioned between the staples 156 and thepath of a drive bar 162.

The surgical stapling apparatus 100 is initially actuated by movement ofthe trigger 112 (FIG. 4) relative to handle assembly 110 causing thedriver 116 to move distally against a sloped edge 142 a of the anvil jawmember 142 thereby causing the anvil jaw member 142 to be moved to theclosed position relative to receiving jaw member 152 of the staplecartridge assembly 150. As the drive bar 162 advances distally withinthe staple cartridge 154, the drive bar 162 urges the staple pushers 160upwardly against the backspan 156 a of the staples 156 driving the legs156 b of the staples 156 through the surgical buttress 11 associatedwith the staple cartridge assembly 150, the tissue “T”, the surgicalbuttress 11 associated with the anvil assembly 140, and towards stapleforming pockets 144 defined in the anvil jaw member 142. The tissuepenetrating tips 156 c of the legs 156 b of the staples 156 are bentwithin the staple forming pockets 144 of the anvil jaw member 142 suchthat the backspan 156 a and the legs 156 b secure the surgicalbuttresses 11 against the tissue “T”.

Upon full actuation of surgical stapling apparatus 100, a knife 118defining a knife blade 119, which is carried by the driver 116, cuts thetissue “T” between the rows of now formed staples 156. Upon movement ofthe anvil assembly 140 to the open position spaced apart from the staplecartridge assembly 150, the surgical buttresses 11 are pulled away fromthe anvil and staple cartridge assemblies 140, 150.

The resulting tissue “T”, divided and stapled closed with the staples156, is illustrated in FIG. 7. Specifically, the surgical buttress 11that was associated with the staple cartridge assembly 150 is securedagainst the tissue “T” by the backspans 156 a of the staples 156 and thesurgical buttress 11 associated with the anvil assembly 140 is securedagainst the tissue “T” by the legs 156 b of the staples 156. Thus, thesurgical buttresses 11 are stapled to the tissue “T” thereby sealing andreinforcing the staple lines created by the staples 156, as well asallowing a clinician to monitor properties on each side of, and through,the stapled tissue “T” via the sensing fiber(s) 20 (FIG. 3) of thesurgical buttresses 11. As discussed above, the sensing fibers 20transmit information to the clinician such that if a specified testcriterion is met, a course of treatment may be selected, e.g.,antibiotic therapy, surgical intervention, etc. On the other hand, if noindicator of an abnormal physiological condition or state is provided,no further action is required on the part of the clinician.

Referring now to FIGS. 8 and 9, an annular surgical stapling apparatus200, for use with a surgical buttress of the present disclosure, isshown. The surgical stapling apparatus 200 includes a handle assembly210, an elongate tubular body portion 220 extending distally from thehandle assembly 210, and an end effector 230 disposed at a distal end ofthe elongate tubular body portion 220. The handle assembly 210 has atleast one pivotable actuating handle member 212, and an advancing member214. The elongate tubular body portion 220 terminates in a staplecartridge assembly 250 of the end effector 230 which includes a pair ofannular arrays of staple receiving slots 252 having a staple 254disposed in each one of the staple receiving slots 252. Positioneddistally of the staple cartridge assembly 250 is an anvil assembly 240of the end effector 230 which includes an anvil member 242 and a shaft244 operatively associated therewith for removably connecting the anvilassembly 240 to a distal end portion of the elongate tubular bodyportion 220 of the surgical stapling apparatus 200.

The staple cartridge assembly 250 may be fixedly connected to the distalend of the elongate tubular body portion 220 or may be configured toconcentrically fit within the distal end of the elongate tubular bodyportion 220. The staple cartridge assembly 250 includes a staple pusher256 including a proximal portion having a generally frusto-conical shapeand a distal portion defining two concentric rings of peripherallyspaced fingers (not shown), each one of which is received within arespective staple receiving slot 252.

A knife 258, substantially in the form of an open cup with the rimthereof defining a knife blade 259, is disposed within the staplecartridge assembly 250 and mounted to a distal surface of the staplepusher 256. The knife 258 is disposed radially inward of the pair ofannular arrays of staples 254. Accordingly, in use, as the staple pusher256 is advanced, the knife 258 is also advanced axially outward.

A surgical buttress 11 a is releasably attached to the anvil assembly240 and/or the staple cartridge assembly 250. As specifically shown inFIG. 10, the surgical buttress 11 a is provided in an annularconfiguration and includes a body portion 12′ defining an aperture 13that is sized and dimensioned to receive the shaft 244 (FIG. 9) of theanvil assembly 240 and allow free passage of the knife 258 (FIG. 9)therethrough. The body portion 12′ of the surgical buttress 11 a may beconfigured as one or more porous and/or non-porous layers as describedabove with regard to surgical buttress 11, and which includes at leastone sensing fiber 20 (FIG. 3) disposed therein, as also described above.

Referring again to FIG. 9, the surgical stapling apparatus 200 anddetachable anvil assembly 240 are used in an anastomosis procedure toeffect joining of intestinal sections. The anastomosis procedure istypically performed using minimally invasive surgical techniquesincluding laparoscopic means and instrumentation. The anvil assembly 240is applied to an operative site either through a surgical incision ortransanally and positioned within a first intestinal tissue section“T1”, and the elongate tubular body portion 220 of the surgical staplingapparatus 200 is inserted through a surgical incision or transanallyinto a second intestinal tissue section “T2”.

Thereafter, a clinician maneuvers the anvil assembly 240 until theproximal end of shaft 244 is inserted into the distal end of the tubularbody portion 220 of the surgical stapling apparatus 200, wherein amounting structure (not shown) within the distal end of tubular bodyportion 220 engages the shaft 244 of the anvil assembly 240 to effectmounting. The anvil assembly 240 and the tubular body portion 220 arethen approximated to approximate the first and second tissue sections“T1”, “T2”. The surgical stapling apparatus 200 is then fired, firingthe staples 254 through the surgical buttresses 11 a as well as thefirst and second tissue sections “T1”, “T2”, effecting stapling of thefirst and second tissue sections “T1”, “T2” to one another and cuttingof the first and second tissue sections “T1”, “T2” by the knife 258 tocomplete the anastomosis. Upon movement of the anvil assembly 240 awayfrom the staple cartridge assembly 250, the surgical buttresses 11 a arepulled away from the anvil and staple cartridge assemblies 240, 250.

As described above, the surgical buttresses 11 a are stapled to thefirst and second tissue sections “T1”, “T2” thereby sealing andreinforcing the staple lines created by the staples 254, as well asallowing a clinician to monitor properties on each side of, and through,the stapled first and second tissue sections “T1”, “T2” via the sensingfiber(s) 20 (FIG. 3).

With reference now to FIG. 11, an exemplary embodiment of a surgicalimplant of the present disclosure is discussed in terms of a surgicalmesh. The surgical mesh may be used to reinforce tissue, and includes atleast one sensing fiber for measuring a physiological parameter of thetissue and/or tissue environment. While the embodiment is directed to anabdominal wall hernia repair procedure, it is envisioned that theprinciples of the present disclosure are equally applicable to a rangeof soft tissue repair procedures, such as to the gall bladder, appendix,lungs, etc.

As shown in FIG. 11, a surgical mesh 11 b includes a porous layer 12″having a fibrous structure including at least one sensing fiber 20. Thesurgical mesh 11 b may have any shape, size, and/or dimension suitablefor a particular surgical application, and is fabricated frombiocompatible material(s) that may be porous, non-porous, orcombinations thereof, as discussed above. In some embodiments, thefibrous structure of the surgical mesh 11 b may be the same as, orsimilar to, surgical implant 10 (FIG. 1), and/or may include additionallayers similar to, or the same as, surgical implant 10 a (FIG. 2).

In embodiments, the sensing fiber 20 of the surgical mesh 11 b isconfigured to measure a physiological parameter of interest related tomonitoring conditions about a soft tissue defect, e.g., herniatedtissue. In some embodiments, the sensing fiber 20 is a mechanicalsensor, an electrical sensor, or an optical sensor adapted to measure aphysical property of the tissue or the tissue environment. For example,the sensing fiber 20 may be configured to measure a load or force (e.g.,strain) related to physical activity, such as intra-abdominal pressure,on a hernia repair site. As another example, the sensing fiber 20 may beconfigured to measure displacement of a surgical mesh indicative of meshmigration. In certain embodiments, the sensing fiber 20 is a straingauge (e.g., an optical strain gauge).

In some embodiments, the sensing fiber 20 of the surgical mesh 11 b isan optical sensor or a chemical sensor adapted to detect and/or quantifyan amount of a material or substance (e.g., a chemical, an analyte, abyproduct, a metabolite, etc.) in tissue or the tissue environmentindicative of a post-surgical condition or state. Accordingly, if thesensing fiber 20 detects the material or substance to be above or belowa pre-determined value or to fall within a pre-defined range, aclinician and/or the patient is alerted so that a proper course ofaction may be taken to accelerate or optimize healing (e.g., to corrector balance the condition). For example, the sensing fiber 20 may beconfigured to measure nitrogen content as a biomarker for protein lossand/or muscle wasting such that if nitrogen levels fall below apre-determined value, a clinician may administer an hGH treatment by,e.g., subcutaneous injection, to improve nitrogen balance and tomaintain and/or increase muscle mass and/or strength.

The surgical mesh 11 b may be introduced through a mesh deploymentdevice and placed over damaged tissue (e.g., a tissue defect). Suitabledevices include those shown and described, for example, in commonlyowned U.S. Pat. No. 5,370,650, entitled “Articulating Mesh DeploymentApparatus,” U.S. Pat. No. 8,317,808, entitled “Device and Method forRolling and Inserting a Prosthetic Patch into a Body Cavity,” U.S. Pat.No. 8,906,045, entitled “Articulating Patch Deployment Device and Methodof Use,” U.S. Pat. No. 9,107,726, entitled “Device and Method forDeploying and Attaching an Implant to a Biological Tissue,” and U.S.Pat. No. 9,655,709, entitled “Mesh Deployment Devices and Kits,” theentire contents of each of which is incorporated herein by thisreference.

The surgical mesh 11 b is secured to healthy tissue “A”, such as anabdominal wall, surrounding a tissue defect “D” (shown in phantom) byfasteners “S” to anchor the surgical mesh 11 b to the tissue “A”. Thefasteners “S” may be staples, sutures, tacks, anchors, among otherfixation devices within the purview of those skilled in the art. Thefasteners “S” may be retained within an end effector of a surgicalfastener delivery device and deployed therefrom to secure the surgicalmesh 11 b to the tissue “A.” Suitable fasteners and surgical fastenerdelivery devices include those shown and described, for example, incommonly owned U.S. Pat. No. 7,229,452, entitled “Tack and TackApplier,” U.S. Pat. No. 7,866,526, entitled “Apparatus for ApplyingSurgical Fasteners to Body Tissue,” U.S. Pat. No. 8,216,272, entitled“Absorbable Anchor for Hernia Mesh Fixation,” the entire contents ofeach of which is incorporated herein by this reference.

The surgical mesh 11 b is secured to the tissue “A” to reinforce thetissue defect “D”, as well as to allow a clinician to monitor propertiesaround the tissue defect “D” via the sensing fiber(s) 20 of the surgicalmesh 11 b. As discussed above, the sensing fibers 20 transmitinformation to the clinician such that if a specific test criterion ismet, a course of treatment may be selected, for example, to minimize orreduce patient morbidity and/or to detect or prevent post-operativerepair failure.

Surgical instruments, such as the surgical staplers the mesh deploymentdevices, and the surgical fastener delivery devices, and the surgicalimplants usable therewith, described herein, may also be configured towork with robotic surgical systems and what is commonly referred to as“Telesurgery.” Such systems employ various robotic elements to assistthe surgeon and allow remote operation (or partial remote operation) ofsurgical instrumentation. Various robotic arms, gears, cams, pulleys,electric and mechanical motors, etc. may be employed for this purposeand may be designed with a robotic surgical system to assist the surgeonduring the course of an operation or treatment. Such robotic systems mayinclude remotely steerable systems, automatically flexible surgicalsystems, remotely flexible surgical systems, remotely articulatingsurgical systems, wireless surgical systems, modular or selectivelyconfigurable remotely operated surgical systems, etc.

The robotic surgical systems may be employed with one or more consolesthat are next to the operating theater or located in a remote location.In this instance, one team of surgeons or nurses may prep the patientfor surgery and configure the robotic surgical system with one or moreof the instruments disclosed herein while another surgeon (or group ofsurgeons) remotely controls the instruments via the robotic surgicalsystem. As can be appreciated, a highly skilled surgeon may performmultiple operations in multiple locations without leaving his/her remoteconsole which can be both economically advantageous and a benefit to thepatient or a series of patients.

The robotic arms of the surgical system are typically coupled to a pairof master handles by a controller. The handles can be moved by thesurgeon to produce a corresponding movement of the working ends of anytype of surgical instrument (e.g., end effectors, graspers, knifes,scissors, etc.) which may complement the use of one or more of theembodiments described herein. The movement of the master handles may bescaled so that the working ends have a corresponding movement that isdifferent, smaller or larger, than the movement performed by theoperating hands of the surgeon. The scale factor or gearing ratio may beadjustable so that the operator can control the resolution of theworking ends of the surgical instrument(s).

The master handles may include various sensors to provide feedback tothe surgeon relating to various tissue parameters or conditions, e.g.,tissue resistance due to manipulation, cutting or otherwise treating,pressure by the instrument onto the tissue, tissue temperature, tissueimpedance, etc. As can be appreciated, such sensors provide the surgeonwith enhanced tactile feedback simulating actual operating conditions.The master handles may also include a variety of different actuators fordelicate tissue manipulation or treatment further enhancing thesurgeon's ability to mimic actual operating conditions.

Reference is made herein to U.S. Pat. No. 8,828,023 entitled “MedicalWorkstation,” the entire content of which is incorporated herein byreference, for a more detailed discussion of the construction andoperation of an exemplary robotic surgical system.

Persons skilled in the art will understand that the devices, systems,and methods specifically described herein and illustrated in theaccompanying figures are non-limiting exemplary embodiments, and thatthe description, disclosure, and figures should be construed merelyexemplary of particular embodiments. It is to be understood, therefore,that the present disclosure is not limited to the precise embodimentsdescribed, and that various other changes and modifications may beeffected by one skilled in the art without departing from the scope orspirit of the disclosure. Additionally, it is envisioned that theelements and features illustrated or described in connection with oneexemplary embodiment may be combined with the elements and features ofanother exemplary embodiment without departing from the scope of thepresent disclosure, and that such modifications and variations are alsointended to be included within the scope of the present disclosure.Accordingly, the subject matter of the present disclosure is not to belimited by what has been particularly shown and described.

1. A monitoring system comprising: a surgical implant configured forimplantation in vivo and including at least one sensing fiber configuredto measure a preselected physiological parameter; and a receiving unitin wireless communication with the at least one sensing fiber andconfigured to receive measurements of the preselected physiologicalparameter.
 2. The monitoring system according to claim 1, wherein thesurgical implant includes a porous layer, and the at least one sensingfiber is disposed within the porous layer.
 3. The monitoring systemaccording to claim 1, wherein the surgical implant is formed from aplurality of fibers, and the at least one sensing fiber is incorporatedinto the plurality of fibers.
 4. The monitoring system according toclaim 1, wherein the surgical implant includes a non-porous layer, andthe at least one sensing fiber is disposed within the non-porous layer.5. The monitoring system according to claim 1, wherein the at least onesensing fiber is an optical fiber.
 6. The monitoring system according toclaim 1, wherein the preselected physiological parameter measured by theat least one sensing fiber is pH.
 7. The monitoring system according toclaim 1, wherein the preselected physiological parameter measured by theat least one sensing fiber is a quantity of an analyte.
 8. Themonitoring system according to claim 1, wherein the preselectedphysiological parameter measured by the at least one sensing fiber isforce.
 9. The monitoring system according to claim 1, wherein the atleast one sensing fiber includes a core and a sheath disposed over thecore.
 10. The monitoring system according to claim 9, wherein the coreincludes a semiconducting element, a conducting element, and aninsulating element.
 11. The monitoring system according to claim 9,wherein the core includes a semiconducting element and a plurality ofconducting elements in contact with the semiconducting element.
 12. Themonitoring system according to claim 11, wherein the plurality ofconducting elements are electrically connected in a circuit. 13-20.(canceled)
 21. The monitoring system according to claim 11, wherein theplurality of conducting elements are electrodes.
 22. The monitoringsystem according to claim 1, wherein the surgical implant is a surgicalbuttress.
 23. The monitoring system according to claim 1, wherein thesurgical implant is a surgical mesh.